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Endpoints in Medical News

InDex Pharmaceuticals AB Engages PharmaVentures to Facilitate the Licensing of Kappaproct(R) After Phase IIa Trial Achieves Clinical Endpoints Early

OXFORD, England, May 18 /PRNewswire/ -- PharmaVentures Ltd, announced today that it has been engaged by InDex Pharmaceuticals AB to advise and assist in out-licensing its first in class therapeutic, Kappaproct (DIMS 0150), for the treatment of steroid resistant / dependent Inflammatory Bowel Disea...

TorreyPines' NGX426, an Oral AMPA/Kainate Receptor Antagonist, Meets Primary Endpoints in Reducing Capsaicin-Induced Pain in Healthy Subjects

LA JOLLA, Calif., Dec. 1 /PRNewswire/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX ) today announced that oral administration of NGX426, an AMPA/kainate-type glutamate receptor antagonist, demonstrated a statistically significant reduction in spontaneous pain, hyperalgesia (abnormally increas...

Cethromycin achieves all endpoints in second pivotal Phase III Trial for treatment for pneumonia

CHICAGO, IL, November 15, 2007, 2007/PRNewswire/: -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), today announced positive results from Trial CL-05, the second of two pivotal phase III clinical trials designed to assess the safety and effectiveness of cethromycin, a novel once-a-day oral ...

Lumension Audiocast With Aberdeen Group Highlights How to Reduce IT Costs By Effectively Managing and Securing Endpoints

Audiocast Outlines How "Best-in-Class" Enterprises Are Making Endpoint Security Management Technology Investments Work Harder for Them to Achieve Better ROI Scottsdale, Ariz. (PRWEB) June 23, 2009 -- In today's fast paced IT environment, financially motivated ...

MAP Pharmaceuticals Phase 3 Trial of LEVADEX(TM) Migraine Product Candidate Meets All Four Primary Endpoints

- Both Rapid and Sustained Pain Relief for up to 48 Hours - - Conference Call to be Held Today at 8:30 a.m. ET - MOUNTAIN VIEW, Calif., May 26 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP ) announced today that the efficacy portion of its first Phase 3 clinical t...

Arena Pharmaceuticals Announces Positive Lorcaserin Pivotal Phase 3 Obesity Trial Results: Meets All Primary Efficacy and Safety Endpoints

- Lorcaserin Very Well Tolerated Throughout Two-Year Study - Conference Call Scheduled for Today at 8:30 a.m. EDT SAN DIEGO, March 30, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA ) announced today positive top-line results from BLOOM (Behavioral ...

Horizon Therapeutics announces 2 pivotal HZT-501 Phase 3 trials meet primary endpoints

Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today announced that two pivotal Phase 3 trials evaluating its lead investigational product candidate, HZT 501, met all primary endpoints. HZT 501, a novel, proprietary fixed-dose combination product containing ibuprofen and ...

Orexigen(R) Therapeutics Announces Second Quarter 2009 Financial Results

...e, compared to a 0.1% reduction in placebo. This difference of 0.5% is clinically and statistically significant (ITT, p<0.001). Key secondary endpoints met in the COR Phase 3 program included significant improvements in cardiovascular and metabolic risk factors such as waist circumference, visceral fa...

Bellicum Pharmaceuticals Announces Initiation of Phase I/II Clinical Trial of Novel Vaccine for Patients With Advanced Prostate Cancer

... progressed at the end of this acute phase will be eligible to receive booster vaccinations every eight weeks for up to one year. Exploratory efficacy endpoints include prostate-specific antigen dynamics, circulating tumor cell count, antigen-specific immune response, and clinical response. Additional informat...

Lexicon Initiates Phase 2 Clinical Trial of LX2931 in Patients With Rheumatoid Arthritis

...efined by the American College of Rheumatology (ACR) as a 20 percent improvement in symptoms associated with rheumatoid arthritis. Multiple secondary endpoints will also be evaluated, including ACR50, ACR70 and DAS28. In addition to LX2931, Lexicon has two other drug candidates progressing in Phase 2 ...
Endpoints in Medical Technology

R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent

SOUTH SAN FRANCISCO, Calif., July 23 /PRNewswire-FirstCall/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL ) today announced that in the TASKi3 Phase 2b clinical trial in rheumatoid arthritis (RA) patients who had failed to respond to at least one biologic treatment, the group treat...

Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk

- Late-Breaking Data from Pivotal BLOOM Trial Presented at the American Diabetes Association's 69th Scientific Sessions Expand on Previously Announced Positive Top-Line Results - NEW ORLEANS, June 6, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA ) announced today...

Isolagen, Inc. Reports Positive Top-line Results from Phase II/III Study of Isolagen Therapy(TM) to Treat Moderate to Severe Acne Scars: Study Meets All Primary Efficacy Endpoints and is Statistically Significant

-Company Provides Update on Cash Position- -Biologics License Application for Wrinkles/Nasolabial Folds Indication Expected To Be Filed Within Two Weeks- EXTON, Pa., March 5 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (Amex: ILE ) announced today positive top-line efficacy results ...

Abbott's XIENCE V(TM) Drug Eluting Stent Outperforms TAXUS(R) in Key Efficacy and Safety Endpoints Out to Two Years

New Analysis of SPIRIT II and SPIRIT III Data Confirms Patients Treated with XIENCE V Are at Lower Risk of Experiencing Death, a Heart Attack or a Repeat Procedure Compared to TAXUS(R) at Two Years WASHINGTON, Oct. 13 /PRNewswire-FirstCall/ -- Data from an independent meta-analysis ...

NicOx Announces Second Naproxcinod Pivotal Phase 3 Study (302) Meets Efficacy Primary Endpoints and Supports Non-Detrimental Blood Pressure Effect

PARIS, September 15 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today announced successful top-line results from the second phase 3 study for naproxcinod in 1020 patients with osteoarthritis of the knee (the 302 study). Both doses of naproxcinod (750 mg and 375 mg bid) met the t...

Agile Therapeutics Achieves Phase 2 Study Endpoints in Key Clinical Trials with New, Innovative Low-Dose Contraceptive Patch

Company to Discuss Phase 3 Plans with FDA PRINCETON, N.J., Sept. 3 /PRNewswire/ -- Agile Therapeutics, Inc., announced today that it successfully completed two key clinical trials in the development of the company's new, innovative low-dose, once-weekly, contraceptive patch, whi...

Isolagen, Inc. Reports Positive Top-line Results from Pivotal Phase III Studies of Isolagen Therapy(TM) in Wrinkles: Studies Meet All Primary Efficacy Endpoints and are Statistically Significant

Investor Conference Call to be held on Wednesday, August 6, 2008 at 8:00 a.m. EXTON, Pa., Aug. 5 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (Amex: ILE) announced today positive top-line efficacy and safety results from two pivotal, Phase III clinical studies ...

Data Presented at American Headache Society's Annual Scientific Meeting Show Primary Endpoint Met as Well as Improvement on Important Secondary Endpoints in Phase IIb Acute Migraine Trial of TorreyPines Therapeutics' Tezampanel

Company's End-of-Phase II Meeting with FDA Set for Sept. 29 LA JOLLA, Calif., June 30 /PRNewswire/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX ) today announced that data presented at the 50th Annual Scientific Meeting of the American Headache Society showed that, in addition to mee...

Phase III Study of Abbott's Investigational TriLipix(TM) in Combination With AstraZeneca's CRESTOR(R) Meets Primary Endpoints on Key Lipids

Data Show TriLipix (ABT-335) in Combination with CRESTOR (rosuvastatin calcium) Improved LDL, HDL and Triglycerides and Had Reported Safety Consistent with Monotherapies SEATTLE, May 31 /PRNewswire-FirstCall/ -- New Phase III data showed that in patients with multiple lip...

Abbott's Phase III Studies of Investigational TriLipix(TM) (ABT-335), in Combination With Statins, Meets Primary Endpoints on Improving LDL, Triglycerides and HDL

TriLipix in Combination With Statins Improved All Three Key Lipids and Had Reported Safety Consistent With TriLipix or Statin Monotherapies CHICAGO, March 31 /PRNewswire-FirstCall/ -- New data from two Phase III studies show that in patients with multiple lipid problems, Abbott's ABT-335 com...

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Endpoints in Medical Products

GreenLight PV Laser System

Description:...selective Vaporization of the Prostate) Procedure for the Treatment of Benign Prostatic Hyperplasia (BPH) allows the urologist to deliver the clinical endpoints of a TURP with the safety and ease of a minimally invasive procedure....
Company:AMS

ACT PLUS Automated Coagulation Timer System

Description:...mated Coagulation Timer. The ACT Plus System is a microprocessor-controlled electromechanical coagulation instrument designed to determine coagulation endpoints in whole blood, citrated whole blood, and plasma samples. Clotting-time results are presented on the instruments Clot Time Display (CTD) and Liquid Cr...
Company:Medtronic Inc.

Obagi Blue Peel System

Features:... Non-ionic blue base with glycerin that acts as a color guide and slows TCA penetration for a more even, uniform distribution. Easy-to-recognize endpoints that signal desired depth, determining outcome. ...
Company:Obagi Medical Products, Inc.

IRIS Medical IQ 810 Infrared Laser

Features:...tor to quickly and easily verify the integrity of the fiber before treatment which is increasingly important with the adoption of MIP procedures where endpoints are not visible. ...
Company:IRIDEX
Endpoints in Medical Definition

Surrogate markers

...ber of instances when studies using surrogate markers have been used to show benefit from a particular treatment, but later, a repeat study looking at endpoints has not shown a benefit, or even a harm. [2] References ^ Cohn JN (2004). " Introduction to Surrogate Markers ". Circulation ...
Endpoints in Biological News

Study suggests obese women should not gain weight

... Medical College. "To say that they should gain even more weight is counter-intuitive, and our study bears that out. Rather than focusing on numerical endpoints with respect to weight gain, we need to focus on making these women healthier by getting them to eat a well-balanced diet." The study grew out of ...

Society of Interventional Radiology Foundation awards $191,000 in grants

...MR Perfusion Parameters With Pathology Following Chemoembolization of Hepatocellular Carcinoma (HCC)," and Brian Jin, "The Correlation of Angiographic endpoints With Perfusion and Clinical Outcomes During Chemoembolization of Hepatocellular Carcinoma," both at Northwestern University, Chicago, Ill."; Lydia ...

NTP finalizes report on Bisphenol A

...cusses many of the uncertainties, including the very limited data from studies in humans and the difficulty in relating the often subtle developmental endpoints in animal studies to human health risks. The NTP Center for the Evaluation of Risks to Human Reproduction (CERHR) conducted the BPA evaluation. ...

Experimental chemotherapy regimen shows promise in treating advanced lung cancer

...l of the American Association for Cancer Research. In a phase II multicenter study of 56 patients with an advanced form of this common lung cancer, endpoints including response rate, progression-free survival, and overall survival from use of S-1 and irinotecan were similar to, or better than, those reporte...

Findings released from 1 of the largest percutaneous coronary intervention trials ever

... patients undergoing angioplasty were randomly assigned to receive either bivalirudin with provisional use of GPI or heparin plus GPI. The two primary endpoints of the trial were major bleeding and net adverse clinical events, a composite of major adverse cardiovascular events (death, reinfarction, stroke or i...

Nucleonics initiates hepatitis B clinical trial with expressed interfering RNA therapeutic

...nized into five escalating dose groups of three patients per group. Primary endpoints are safety-related, with secondary endpoints tracking biological markers of efficacy, including HBV viral levels in the ...

2 carotid artery stenting studies show results comparable to AHA guidelines

...inical setting by physicians with varying levels of experience. The primary endpoints were death, stroke and MI at 30 days. The demographics of patients in both trials were similar. The 30-day composite endpoints of stroke and death for patients in the CAPTURE 2 and EXACT studies were: ...

What's in the water? Estrogenic activity documented in fish caught in Pittsburgh's rivers

...aught. Additionally, the consumption of river-caught fish, especially by semi-subsistence anglers, may increase the risk for endocrine-mediated health endpoints like some cancers and developmental problems." ...

Study shows interruption of antiretroviral therapy increases risk of disease and death

...tunistic disease or died from any cause. Analysis of study data showed that those on episodic therapy had more than twice the risk of developing these endpoints compared to those in the continuous therapy group. In addition, participants in the episodic group experienced significantly more cardiac, renal, and ...

Antioxidant selenium offers no heart-disease protection

...ion between selenium supplementation on any of the endpoints studied: coronary heart disease, stroke or deaths ...Stranges said. There also was no difference in the endpoints based on the level of selenium at baseline. In add...tion, the lack of significant association with CVD endpoints was confirmed even in the 246 participants who had...
Endpoints in Biological Technology

Orexigen(R) Therapeutics Announces First of Four Phase 3 Trials of Contrave(R) Meets Co-Primary and Key Secondary Endpoints

SAN DIEGO, Jan. 8 /PRNewswire-FirstCall/ -- Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX ) today announced that the first of four Phase 3 trials of its lead investigational product Contrave(R) (naltrexone sustained release (SR)/bupropion SR) met its co-primary and key secondary endpoints, sh...

Genzyme Study of Myozyme(R) for Late-Onset Pompe Patients Meets Co-Primary Efficacy Endpoints

CAMBRIDGE, Mass., Dec. 13 /PRNewswire-FirstCall/ -- Genzyme Corp. (Nasdaq: GENZ ) announced today that its Late Onset Treatment Study (LOTS) of Myozyme(R) (alglucosidase alfa) met its co-primary efficacy endpoints. The study was undertaken to evaluate the safety and efficacy of Myozyme in juv...

AutoImmune Inc. Reports 2009 Second Quarter Financial Results

...rogressive multiple sclerosis (SPMS). In addition, there were no statistically significant differences between dirucotide and placebo on the secondary endpoints of the study. Eli Lilly and BioMS also announced that they would discontinue ongoing clinical trials and review available data. Chairman of the Boar...

InterMune Reports Second Quarter 2009 Financial Results and Business Highlights

... CAPACITY 2 demonstrated a statistically significant effect on both the primary endpoint of change in percent predicted FVC at Week 72 and secondary endpoints of progression-free survival and categorical change in percent predicted FVC. While CAPACITY 1 did not achieve statistical significance on...

Amicus Therapeutics Announces Second Quarter 2009 Financial Results

...l capillary GL-3 as measured in kidney biopsies using histology. Secondary endpoints will include safety and tolerability, kidney GL-3 as measured in urine, and...luate safety, dosing, and preliminary efficacy, as measured by the standard endpoints in Gaucher disease. The Company expects to report the results early in the...

GeoVax Labs, Inc. Provides Clinical Studies Update

... of Research and Development. "The therapeutic trials should move more rapidly than the preventative trials because each participant provides not only endpoints for safety and immunogenicity, but also an endpoint for protective efficacy. But, before these trials can scale up, we need to demonstrate safety for ...

Ceregene Receives Additional Grant From Michael J. Fox Foundation to Expand Long-Term Testing of CERE-120 Patients

...nnounced, however, that CERE-120 suggested improvement on several secondary endpoints at 12 months, and at 18 months, a statistically significant treatment effect on the primary endpoint emerged, while several additional secondary endpoints also showed improvement. In contrast, on no measure did sham patients perfo...

Nile Therapeutics, Inc. Announces Dosing of First Patient in Phase 2 Study of CD-NP for the Treatment of Acute Heart Failure

...bility of CD-NP when infused for up to 72 hours in patients with acute heart failure and mild to moderate renal insufficiency. Additional exploratory endpoints will include assessments of CD-NP's ability to relieve symptoms of acute heart failure and its effects on biomarkers of heart failure and renal functi...

DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointestinal GVHD

...l trial, namely median time-to-treatment failure through Day 50 (p-value 0.1177), orBec(R) did achieve statistical significance in other key secondary endpoints such as the proportion of patients free of GVHD at Day 50 (p-value 0.05) and Day 80 (p-value 0.005) and the median time to treatment failure through D...

AEterna Zentaris Partner, Keryx, Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial with Perifosine (KRX-0401) for the Treatment of Multiple Myeloma

...le myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. Juergen Engel...of therapy. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. About Mult...
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